Trial Comparing Higher-Dose Iron 45 mg and 60 mg Versus Standard 30 mg Iron in Pregnancy Supplements to Prevent Moderate and Severe Maternal Anemia in Tanzania

What this Trial Is About

Researchers are investigating the impact of multiple micronutrient supplements MMS with varying iron doses on preventing moderate or severe anemia in pregnant women. This Phase 3 randomized controlled trial focuses on comparing MMS containing 60 mg and 45 mg of iron against the standard MMS containing 30 mg of iron, aiming to provide guidance for countries like Tanzania on the most suitable iron dose during pregnancy. Participants are randomly assigned to one of three groups receiving MMS with either 30 mg, 45 mg, or 60 mg of elemental iron daily from the time of randomization until delivery. All groups receive the standard UNIMMAP formulation with 15 micronutrients, differing only in the iron content. The supplements are taken orally once a day as part of routine antenatal care. During the study, pregnant women will be monitored through the third trimester and up to 6 weeks postpartum. Researchers will assess anemia levels, hemoglobin concentration, iron status, pregnancy complications, maternal symptoms, birth outcomes, and infant health measures. Study visits include evaluations of blood tests, maternal and infant health, and questionnaires on symptoms such as fatigue and depression. The total participation duration covers pregnancy through 6 weeks after delivery.

Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania